Publication:

A prospective pharmacovigilance study to evaluate adverse effect profile of first line anti-tubercular drugs in newly diagnosed sputum positive patients

Background Tuberculosis (TB) continues to remain one of the most pressing health problems in India with highest TB burden country in the world. Anti-tubercular therapy (ATT) induced organ toxicities are potentially serious ADRs of first line ATT regimen. The underlying mechanism of ATT-induced ADRs especially hepatotoxicity and the factors predisposing to its incidence which is significantly high in Indians are not clearly understood. It's vital to emphasize on ATT induced ADRs as it has direct influence on therapeutic outcome; result in high dropout rate and potential to develop MDR/XDR cases. ADR monitoring help us to revise the treatment protocol thereby improve treatment adherence and therapeutic outcome. Objective of this study is therefore designed to explore and monitor ADRs of first line anti-TB drugs.

Methods In this prospective observational study 60 TB patients (18-70 yrs) of either sex, newly sputum positive with normal parameters were included. Patients were followed up for six months aiming primarily to assess rate of ADRs and to identify preventable and potentially serious ADRs of anti-TB drugs. The ADRs of ATT on various organ systems (heart, kidney and liver), biochemical and haematological parameters were assessed and compared after 2 and 6 months; gender and age specific adverse events were also studied. Data obtained was analysed using student’s t-test of OpenEpi statistical software.

Results Study clearly revealed that ATT exhibit significant increase in toxicity markers viz. liver enzymes (p<0.01), urea and creatinine (p<0.01), ESR (p<0.05) and PTINR (p<0.01), wherein decrease in Hb% (p<0.01) when compared to baseline.

Conclusions ATT related ADRs is the major cause of dropouts and development of MDR/XDR cases. It's crucial to develop strategies to ameliorate ADRs both to improve the quality of patient care and to control TB safely. The data obtained from present study may be helpful in developing these effective strategies.